Hanford SEC Review (SEC‐00155)

Summary of SC&A Report

Arjun Makhijani

Prepared for the September 12, 2012,

Hanford Work Group Teleconference Meeting
Background to the SC&A Review of P

SEC‐00155

• SEC Petition SEC‐00155 is focused on the Hanford 200 Are

1987–1989 period.

• Basis of the petition: The bioassay data for the Plutonium 

Plant (PFP) in the 200 Area generated by U.S. Testing Com

(UST) are not trustworthy and should not be used for dos

reconstruction because of fraud and mishandling of data 

company. Among other things, this problem was detailed 

U.S. Environmental Protection Agency (EPA).

• The NIOSH Evaluation Report (April 28, 2011) found that 

data mishandling had not affected bioassay data, and tha

data were usable for dose reconstruction for the period i

• Thereafter, the Board asked SC&A to review the petition 

NIOSH Evaluation Report (ER). The SC&A report was sent Hanford Work Group on August 7, 2012.
SC&A Document Review

SC&A reviewed a large volume of documents incl

• The petition and the ER

• Documents related to the EPA investigation of UST

• Internal UST and PNL audits of bioassay data• The 1990 and 1991 external reviews of the UST bio

program

• Documents supplied by the petitioner and the petit

representative

• Non‐public documents related to the investigation 
SC&A Interviews and Other Rese

SC&A interviewed (by teleconference call)

• The petitioner and the petitioner’s representative• The external bioassay expert during the May 1990 external oversight

• One of the two external experts who participated in the May 1990 ov

DOE.

• Two of the external experts who conducted the 1991 retrospective ov

Hanford Work Group member Brad Clawson participated in the interv

Glover from NIOSH and a DOE classification officer were also present 

interviews. All interviews were reviewed by the classification officer a

interviewees.SC&A also sent questions to two PNL personnel familiar with the bioa

program during the period in question.Finally, SC&A reviewed data quality issues, including MDAs. SC&A spe

reviewed bioassay data for plutonium, uranium, americium‐241, stron

and neptunium, as well as four completed dose reconstructions to exa

use of a certain kind of bioassay data.

Detailed documentation of the above is available in the SC&A report.
Did Fraud Affect UST Bioassay D

• SC&A conducted extensive research to locate any evidence of f

mishandling of data in the UST bioassay program.

• SC&A asked the petitioner and the petitioner’s representative 

documentation or personal knowledge of fraud in the UST bioa

program. None of the information provided direct evidence of that program.

• SC&A conducted detailed interviews regarding two issues pote

related to fraud—one about an edit to a QC file and one regardpotential withholding of data during the 1991 review—but did 

evidence of it.

• No motive for fraud in the bioassay program was found in any o

reviews. Crude levels of fraud could have been detected durin

and 1991 reviews.

• SC&A concluded that to all available evidence, the UST bioass

were unaffected by fraud and mishandling of data. However, 

definitive finding is possible at this time, since none of the int

external audits at the time were structured to detect sophisti
Two Views of Data Relating to F

• The petitioner, as well as the DOE, PNL, and the EPA, indicated 

ways that if any part of UST data was affected by knowing and 

manipulation of tests or data, then all data should be regarded 

This reasoning was explained by the then

‐DOE Site Manager in

deposition 1991. PNL terminated the UST subcontract, includi

bioassay program, for default in 1990.

• In contrast, the external oversight and retrospective reviews in 

1991 found the bioassay data to be acceptable, despite some qassurance and other issues. This view was generally confirmed 

SC&A interviews. One expert interviewee said he would give

a 

yes” to the usability of the data. In other words, these reviews 

conclude that the bioassay data were unusable because of issu

to fraud that had been raised in the chemical side of the UST p

because of QA problems.

• In 1991,

a court stated that the PNL termination of the UST sub

for default was not warranted, though termination for “convenpermissible.
Quality Assurance Issues

• The problems of QA with the work of UST were long

ones, stretching back to the 1960s. There is also evid

that both UST and PNL made efforts to correct theseproblems. However, their persistence does raise a g

question about the quality of the UST bioassay progr

well as the oversight of that program by PNL. It mus

noted that the pre‐1987 data quality issues have no 

bearing on the usability of the 1987–1989 data.

• Some of these problems are related to the failure to 

contractual minimum detectable activities (MDAs), w

some cases (e.g., strontium‐90) were more stringent 

to then‐prevailing industry norms.
Quality Control File Editin

• The May 1990 oversight review found an edited Qua

Control (QC) file. This edit appears to have

a reason

explanation, based on the memory of one of the exp

discovered the edited file in May 1990. There is no p

that can verify that only

a minor change not involvin

was made. However, the fact that the changed QC dwas flagged when it was made would lend support t

hypothesis that the change was made to correct an e

rather than to manipulate data. This observation de

the memory of the expert of events over two decade

which there is no auditable paper trail.
Were Data Withheld from the 19

Review?

• SC&A believes there is some uncertainty regarding the

completeness of the data in the possession of PNL at the 

the retrospective review in 1991; however, there is no ev

that records were withheld to hinder the review or affect 

way.

• Any unavailable records appear to have been the result o

procedures for records transfer between UST and PNL thaby PNL. The available evidence from the time, as well as 

extensive interviews and on‐the‐record exchanges done b

indicate that the 1991 retrospective review team had the 

needed to do its work and arrive at valid conclusions. Th

conclusions were that (1) overall, the team found the bio

program to be sound, and (2) the team found no evidenc

or data manipulation in the bioassay program.
The Bottom Line: A Policy Que

The bottom line regarding the issue of fra

policy question for the Board:

 Should bioassay data, which to all av

evidence are unaffected by fraud, bu

generated by a company that was

dismissed because of data manipula

and fraud in another technically unr

area (chemicals), be trusted for use 

reconstruction?
Other Data Issues, 1987–19

• The internal audits, external oversight reviews, and S

review of the bioassay data all indicated some qualit

problems with the data, including in particular a failu

meet contractual Minimum Detectable Activity levelcases.

• Fecal data had never been subjected to quality assur

sampling.

• SC&A concluded that these problems did not invalid

bioassay data, but that appropriate adjustments wernecessary in some cases prior to the use of the data 

reconstruction.
Two Findings

• Finding 1: SC&A’s review of four cases (not

a statistic

sample) that used fecal data in the dose reconstruct

revealed that in one case, the fecal data were not us

accordance with the established procedure. This aphave resulted in an underestimate of the plutonium 

that case.

• Finding 2: There is less confidence in the fecal samp

since no Quality Assurance (QA) samples were ever a

in the period under review. As one of the May 1990 

experts noted in an interview, QA samples are neede

assure that the results are credible. It does not nece

mean that results are not credible, but it certainly is

weakness of the program that there were no fecal Q

samples.” The added uncertainty arising from this p

should be addressed in dose reconstruction.
End of Slides

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